U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?
Obstet Gynecol
; 127(1): 18-22, 2016 Jan.
Article
in En
| MEDLINE
| ID: mdl-26646134
ABSTRACT
The U.S. Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Uterine Neoplasms
/
Practice Guidelines as Topic
/
Morcellation
/
Leiomyoma
/
Leiomyosarcoma
/
Neoplasm Seeding
Type of study:
Guideline
/
Risk_factors_studies
Limits:
Female
/
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Obstet Gynecol
Year:
2016
Document type:
Article